Instrument system for use with an interspinous implant

ABSTRACT

A surgical instrument system comprises surgical instruments for use with an implantable interspinous device having at least one pair of wings for securing the implantable device to a spinous process. The instrument system may include a surgical instrument for expanding or spreading the pair of wings to accommodate the spinous process. Further, a surgical instrument may be provided for crimping or compressing the pair of wings against the spinous process for secure attachment of the device to a vertebra. The surgical instruments may be configured similar to pliers and apply force to the pair of wings within a predetermined range so as to avoid damage, weakening or breakage of the pair of wings. The surgical instrument system may also include interspinous devices of differing sizes.

This application claims benefit of U.S. Provisional Application No.60/796,256, filed Apr. 28, 2006, the entire contents of which areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to devices and methods for implanting andsecuring spinal implants. Specifically, the present invention pertainsto surgical instruments and instrument systems for implantinginterspinous devices.

BACKGROUND OF THE INVENTION

Diseases of the spine cause significant morbidity. These diseasesinclude abnormalities of the vertebrae, the intervertebral discs, thefacet joints, and connective tissue around the spine. Such abnormalitiescan be caused by a number of factors, such as mechanical injury, and caninclude degenerative disc disease, instability to the spine, vertebralmisalignment, and abnormal motion between adjacent vertebrae. Moresevere disease may result in wear to the vertebral bony surfaces orcause nerve compression, and may ultimately produce severe pain.Further, these conditions are often chronic and progressive problems.

The treatments for spinal disorders may include long-term medicalmanagement or surgery. Medical management is generally directed atcontrolling the symptoms, such as pain, rather than correcting theunderlying problems. For some patients this may require chronic use ofpain medications, which may alter patient mental state or cause othernegative side effects.

Another treatment option is surgery, which is often highly invasive andmay significantly alter the existing spinal anatomy and function. Forexample, one surgical treatment for certain spinal conditions includesspinal fusion, whereby two or more vertebrae may be joined using bonegrafts and/or synthetic implants. Fusion is irreversible and maysignificantly alter vertebral range-of-motion. Further, current surgicalprocedures are often only applicable to patients in a significantlyprogressed disease state.

Consequently, spinal surgeons have begun to develop more advancedsurgical procedures and spinal stabilization and/or repair devices thatare less invasive, may be reversible, and cause a less drasticalteration in the patient's normal anatomy and spinal function. Theseprocedures may be used at an earlier stage of disease progression and,in some situations, may halt or reverse disease progression. Forexample, some spinal treatment systems include interspinous devices.Interspinous devices may be implanted between the spinous processes oftwo vertebrae or between the spinous process of the L5 vertebrae and thesacrum. These devices may provide various degrees of controlled movementof the spine, while supporting the adjacent vertebrae.

Some interspinous devices include an interspinous body portion that isanchored to adjacent spinous processes by wings extending from the bodyportion on opposite sides of the spinous process. Further, in somecases, the wings may be formed from a malleable material such astitanium. To facilitate implantation and secure attachment of the wingsto the spinous processes, it may be desirable to bend or crimp the wingsto control the distance between wings on opposite sides of a spinousprocess. However, bending or crimping the wings may be difficult usingtypical surgical instruments. Further, it may be desirable to bend orcrimp opposing wings evenly to ensure appropriate attachment to thespinous process and to prevent undesirable distortion of the implantshape.

The present disclosure provides surgical instruments and instrument setsfor use with interspinous devices. The surgical instruments mayfacilitate bending and/or crimping of interspinous devices to facilitateimplantation and secure attachment of the devices to spinous processes.

SUMMARY OF THE INVENTION

One aspect of the present disclosure includes a surgical instrument. Theinstrument may include a first elongated section having a first surfaceregion configured to contact an implantable device and a secondelongated section having a second surface region configured to contactthe implantable device. The instrument may further include a hingeregion connecting the first elongated section to the second elongatedsection such that the first surface region of the first elongatedsection and second surface region of the second elongated section aremobile with respect to one another. Further, the instrument may includea guide member operatively connected to the first elongated section andsecond elongated section at the hinge region such that during movementof the first surface region of the first elongated section and secondsurface region of the second elongated section the guide member ismaintained at a fixed symmetrical position with respect to the firstsurface region of the first elongated section and second surface regionof the second elongated section.

A second aspect of the present disclosure includes a surgical instrumentset. The instrument set may include a spinal implant and a surgicalinstrument. The implant may include a first implant body portion and atleast two elongated wing members configured to engage opposite sides ofa vertebral spinous process. The instrument may include a firstelongated section having a surface region configured to contact animplantable device and a second elongated section having a secondsurface region configured to contact the implantable device. Theinstrument may further include a hinge region connecting the firstelongated section to the second elongated section such that the firstsurface region of the first elongated section and second surface regionof the second elongated section are mobile with respect to one another.Further, the instrument may include a guide member operatively connectedto the first elongated section and second elongated section at the hingeregion such that during movement of the first surface region of thefirst elongated section and second surface region of the secondelongated section the guide member is maintained at a fixed symmetricalposition with respect to the first surface region of the first elongatedsection and second surface region of the second elongated section.

A third aspect of the present disclosure includes a method of securingan implant adjacent a spinous process. The method may include selectingan implant having a first body portion and at least two elongated wingmembers configured to engage opposite sides of a vertebral spinousprocess. The method may further include positioning the first bodyportion adjacent a first spinous process and substantially evenlydisplacing each wing member in a first direction relative to a centerpoint between the two elongated wing members to move the two elongatedwing members toward one another to secure the elongated wing members onopposite sides of a spinous process.

A fourth aspect of the present disclosure includes a surgicalinstrument. The instrument may comprise a first surface configured tocontact a portion of an implantable device and a second surfaceconfigured to contact a portion of an implantable device. The instrumentfurther includes a first handle portion connecting the first surface andconfigured to translate a force to the first surface and a second handleportion connected to the second surface and configured to translate aforce to the second surface. In addition, the device includes a guidemember configured to center and hold the implantable device relative tothe surgical instrument in a manner that permits the first and secondsurfaces to substantially evenly displace the first and second portionsof the implant as the first and second surfaces contact the implantabledevice.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory only,and are not restrictive of the invention, as claimed.

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

Additional objects and advantages of the invention will be set forth inpart in the description that follows or may be learned by practice ofthe invention. The objects and advantages of the invention will berealized and attained by means of the elements and combinationsparticularly pointed out in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a portion of a surgical kit, including a surgicalinstrument and an implant, according to an exemplary disclosedembodiment.

FIG. 2A illustrates a perspective view of the surgical instrument of thesurgical kit of FIG. 1, according to an exemplary disclosed embodiment.

FIG. 2B illustrates an exploded view of the surgical instrument of FIG.2A.

FIG. 2C illustrates a perspective view of an end region of the surgicalinstrument of FIG. 2A without a guide member, according to an exemplarydisclosed embodiment.

FIG. 2D illustrates a perspective view of an end region of the surgicalinstrument of FIG. 2A with a guide member, according to an exemplarydisclosed embodiment.

FIG. 2E illustrates a perspective view of an alternative configurationof the surgical instrument of FIG. 2A, according to another exemplarydisclosed embodiment.

FIG. 2F illustrates another perspective view of the surgical instrumentof FIG. 2E.

FIG. 3A illustrates a perspective view of the surgical instrument ofFIG. 2A engaging an interspinous implant.

FIG. 3B illustrates an end view of the surgical instrument of FIG. 2Aengaging an interspinous implant before compression of the implant'swings.

FIG. 3C illustrates an end view of the surgical instrument of FIG. 2Aengaging an interspinous implant after compression of the implant'swings.

FIG. 3D illustrates a perspective view of the underside of the endregion of the surgical instrument of FIG. 3A, according to an exemplaryembodiment.

FIG. 4 illustrates another portion of a surgical kit, including asurgical instrument and an implant, according to an exemplary disclosedembodiment.

FIG. 5D illustrates a perspective view of another surgical instrument,according to another exemplary disclosed embodiment.

FIG. 5A illustrates another perspective view of the surgical instrumentof FIG. 4, according to an exemplary disclosed embodiment.

FIG. 5B illustrates an exploded view of the surgical instrument of FIG.5A, according to an exemplary disclosed embodiment.

FIG. 5C illustrates an exploded view of an end region of the surgicalinstrument of FIG. 5A, according to an exemplary disclosed embodiment.

FIG. 6A illustrates a top view of the surgical instrument of FIG. 5Aengaging an interspinous implant.

FIG. 6B illustrates an enlarged top view of a front end of the surgicalinstrument of FIG. 6A engaging an interspinous implant before expansionof the implant's wings.

FIG. 6C illustrates an enlarged view of the surgical instrument of FIG.6A engaging an interspinous implant after expansion of the implant'swings.

FIG. 7A illustrates a portion of a surgical kit, including a sizing andinsertion implement, according to an exemplary disclosed embodiment.

FIG. 7B illustrates the implement of FIG. 7A engaging an interspinousimplant, according to an exemplary disclosed embodiment.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

Reference will now be made in detail to the present exemplaryembodiments of the invention, examples of which are illustrated in theaccompanying drawings. Whenever possible, the same reference numberswill be used through out the drawings to refer to the same or likeparts.

Implantable interspinous devices 30 can be used to treat a variety ofsurgical conditions, including, for example, degenerative disc diseaseand spinal stenosis. These devices 30 generally include an interspinousbody portion 40 that is placed between the spinous processes of adjacentvertebrae, or the L5 spinous process and the sacrum. The devices 30further include structures that allow the interspinous body to besecured between the spinous processes. For example, some devices caninclude a pair of wings 50, 60 that extend on opposite sides of aspinous process.

The interspinous body portion of an interspinous implantable device maybe provided in a variety of different sizes to facilitate implantationinto interspinous spaces (the space between two adjacent interspinousprocesses) of different sizes. However, the wing portions of suchinterspinous devices may need to be adjusted to allow implantationaround a selected spinous process, and to provide sufficient compressiveforce to the spinous process to secure the implant in place.

To facilitate adjustment of the space between the wings and theresultant “fit” of the device relative to the spinous processes,surgical instruments to bend or expand the wings during insertion of thedevice into the interspinous space and to crimp or compress the wingsafter implantation of the device are provided. These surgicalinstruments may be sold separately or sold in a kit with one or moreimplants. One or both of the surgical instruments may be provided in thekit. The surgical instruments may be used in separate procedures ortogether in the same procedure. For example, it may be necessary only tocrimp or compress the wings during the surgical procedure andunnecessary to expand or spread the wings prior to insertion.Alternatively, it may be necessary to spread or expand the wings priorto insertion and unnecessary to subsequently compress or crimp the wingsafter insertion of the interspinous implant.

FIG. 1 illustrates a portion of a surgical kit or system 10, including asurgical instrument 20 and an implantable device 30, according to anexemplary disclosed embodiment. As shown, implantable device 30comprises an interspinous implant. Implantable device 30 may include aU-shaped body portion 40 configured to be positioned below a spinousprocess (not shown). Implantable device 30 may further include at leastone pair of wings 50, including a first wing 52 and second wing 54. Pairof wings 50 may extend from an upper surface 56 of body portion 40 andmay be configured to engage a spinous process when implanted. Further,in some embodiments, implantable device 30 may include a second pair ofwings 60 that may extend from a lower surface 66 of body portion 40 andmay be configured to engage a second spinous process (not shown).Exemplary implants suitable for use with the present surgical instrument20 and included with the instrument set 10 are described in detail inU.S. Pat. No. 5,645,599 to Jacques Samani, which is titled, “InterspinalVertebral Implant,” and U.S. Provisional Patent Application No.60/868,080 filed Nov. 30, 2006 and entitled “Interspinous VertebralStabilization System” both of which are hereby incorporated by referencein their entirety.

In some embodiments, the surgical instruments of the present disclosurewill facilitate symmetric adjustment of the wings 52, 54 of implantableinterspinous devices 30. For example, to ensure appropriate placementand securement of a device 30, it may be desirable to bend the wings 52,54 symmetrically to center the spinous process between the wings and/orprovide an appropriate compressive force to the spinous process.However, due to variations in design tolerances and production, thethicknesses of the wings 52, 54 may vary slightly from one another,which could affect the ease with which they bend or the amount ofbending achieved, and thus produce asymmetric bending on opposing wings.The surgical instruments of the present disclosure can facilitatesymmetric bending by ensuring symmetric displacement of the wings tocompress the wings 52, 54 onto a spinous process or to expand the wings52, 54 before implantation. This symmetric displacement of the wings canbe accomplished even with variations in wing thickness or materialproperties.

Surgical instrument 20 may be used to facilitate secure attachment ofimplantable device 30 to bone. As described below, instrument 20 may beused to bend or compress the pair of wings 50 or the pair of wings 60,thereby crimping the wings of a pair of wings 50, 60 to a spinousprocess therebetween. Further, although FIG. 1 illustrates an exemplaryembodiment of implantable device 30 that may be included in surgicalsystem 10, it is understood that any suitable implantable device may beselected wherein implantable device 30 includes at least one pair ofwings 50, 60 that may be compressed by surgical instrument 20 andconfigured to secure implantable device 30 to at least one spinousprocess. Additionally, surgical instrument 20 may be adapted to be usedto crimp extending portions of implants intended to be used in areasother than the spine. For example, some interspinous implants may beadapted for placement between the L5 spinous process and the sacrum.Exemplary interspinous implants that may be used for treatment of thelumbosacral region are described in detail in U.S. Patent PublicationNo. 2006/0241601A1, to Frank Trautwein et al., which is titled,“Interspinous Vertebral and Lumbosacral Stabilization Devices andMethods of Use,” and which is hereby incorporated by reference in itsentirety.

In some embodiments, the surgical instruments of the present disclosurewill facilitate symmetric adjustment of the wings 52, 54 of implantableinterspinous devices 30. For example, to ensure appropriate placementand securement of a device 30, it may be desirable to bend the wings 52,54 symmetrically to center the spinous process between the wings and/orprovide an appropriate compressive force to the spinous process.However, due to small variations in design tolerances and production,the wings 52, 54 may have small variations in thickness which couldaffect the easy with which they bend, and produce asymmetric bending onopposing wings. The surgical instruments of the present disclosure canfacilitate symmetric bending by ensuring symmetric displacement of thewings to compress the wings 52, 54 onto a spinous process or to expandthe wings 52, 54 before implantation. This symmetric displacement of thewings can be accomplished even with variations in wing thickness ormaterial properties.

FIG. 2A illustrates a perspective view of surgical instrument 20 of FIG.1, according to an exemplary disclosed embodiment, and FIG. 2Billustrates an exploded view of surgical instrument 20 of FIG. 2A. Asshown in FIGS. 2A and 2B, instrument 20 includes a first handle portion200 and a second handle portion 210. First handle portion 200 may beconnected with a first elongated section 220, and second handle portion210 may be connected with a second elongated section 230. First andsecond handle portions 200, 210, may be integrally formed with first andsecond elongated sections 220, 230, respectively. Alternatively, theelements may be separately formed and then connected. Further, firsthandle portion 200 and second handle portion 210 may be operativelyconnected to one another at a hinge region 240, as indicated in FIGS. 2Cand 2D. Hinge region 240 may include a hinge connector 250, as shown inFIG. 2B. Hinge connector 250 may include any suitable connector type,such as a screw, a bolt, a pin, or other suitable connector.

A leaf spring mechanism 70 may also be provided between first handleportion 200 and second handle portion 210 to provide a biased,resistance force between first and second handle portions 200, 210. Leafspring mechanism 70 may comprise two leaf springs 72, 74. One of theleaf springs 72 may terminate at a male portion 76, while the other leafspring 74 may terminate at a female portion 78, as shown. Leaf springs72, 74 may rest against one another in a freely movable, hingedconfiguration. This hinged configuration enables leaf springs 72, 74 tofreely pivot with respect to one another. Each of leaf springs 72, 74may be attached to a respective handle portion 200, 210 with a fastener90. As shown in detail in FIG. 2B, leaf springs 72, 74 may attach tofirst and second handle portions 200, 210, respectively, by securingfasteners 90 through holes 92 on leaf springs 72, 74, and into holes 94of first and second handle portions 200, 210. Fastener 90 may compriseany suitable connector such as, for example, a screw, a bolt, or a pin,as is commonly used in the art.

A surgeon may grasp surgical instrument 20 by first handle portion 200and second handle portion 210, and by increasing or decreasing thedistance between first handle portion 200 and second handle portion 210,may correspondingly increase or decrease the distance between firstelongated section 220 and second elongated section 230. In someembodiments, as the distance between first handle portion 200 and secondhandle portion 210 is increased, the distance between first elongatedsection 220 and second elongated section 230 will increase. Conversely,as the distance between first handle portion 200 and second handleportion 210 is decreased, the distance between first elongated section220 and second elongated section 230 will decrease.

Hinge region 240 may include at least two connector pieces 260, 270 anda guide member 280. FIG. 2C illustrates a perspective view of an endregion of surgical instrument 20 of FIG. 2A without a guide member. Asshown, first connector piece 260 may form a rotatably mobile connectionwith first elongated section 220, and second connector piece 270 mayform a rotatably mobile connection with second elongated section 230.Connector pieces 260, 270 may further form a common rotatably mobileconnection 290 with one another. Further, common connection 290 may forma second common connection 300 with guide member 280, as shown in FIG.2D. Connector pieces 260, 270 may secure guide member 280 in a fixedposition relative to first elongated section 220 and second elongatedsection 230 during movement of first elongated section 220 and secondelongated section 230 about hinge region 240.

Guide member 280 and connector pieces 260, 270 may facilitate symmetricdisplacement of wings 52, 54. For example, as noted previously, due todesign tolerances and production variables, the thicknesses and materialproperties of wings 52, 54 may vary slightly. Therefore, if equalbending forces are applied to each wing 52, 54 the displacement ordegree of bending achieved for each wing 52, 54 may vary, therebyproducing asymmetric engagement with a spinous process. The guide member280 and connector pieces 260, 270 provide symmetric displacement ofwings 52, 54 even when the dimensions and/or material properties ofwings 52, 54 are different.

In some embodiments, the connection between guide member 280 andconnector pieces 260, 270 may include a slidable connection. Forexample, as shown in FIG. 2D, guide member 280 may include a groove 310in which a protrusion 315 from one connector piece 260, 270 rests. Insome embodiments, groove 310 may include an elongated groove alignedwith a central longitudinal axis 58 of surgical instrument 20, as shownin FIG. 2D.

FIG. 2E illustrates a perspective view of a surgical instrument 20′,according to another exemplary disclosed embodiment. Surgical instrument20′ is identical to surgical instrument 20, but with an additionalvisual gauge element 80. As shown in greater detail in FIG. 2F, thegauge element 80 comprises two arms 82, 84, each arm being attached to ahandle region 200, 210, respectively, of surgical instrument 20′. Thefree ends of arms 82, 84 are configured to slide against one anotherwhen the surgical instrument 20′ is engaged. Marks 86 on arms 82, 84 arealigned as the surgical instrument 20′ is compressed or squeezedtogether, thereby indicating to the user the distance between the pairof wings 50, 60. Marks 86 may include numerals, scores, color-codedbars, or other visual indicators which are intended to line up on arms82, 84. Thus, gauge element 80 helps to make surgical instrument 20′function much like a caliper. In this manner, surgical instrument 20′may also serve as a measuring device, allowing the user to measure thedistance between the pair of wings 50, 60 prior to or afterimplantation.

As noted previously, surgical instrument 20 may be used as crimpingpliers to compress or bend pair of wings 50, 60 of implantable device30. FIG. 3A illustrates a perspective view of the surgical instrument 20of FIG. 2A engaging interspinous implantable device 30. First elongatedsection 220 may include a first surface 330 configured to engage a firstwing 52 of pair of wings 50 and to exert a compressive force on firstwing 52. Second elongated section 230 may include a second surface 340configured to engage a second wing 54 of pair of wings 50 and to exert acompressive force on second wing 54. Further, guide member 280, beingoperably connected to first elongated section 220 and second elongatedsection 230 by connector pieces 260, 270, may facilitate the productionof a symmetric displacement or bending of wings 52, 50 of pair of wings50, and/or application of approximately symmetric compressive forces onfirst wing 52 and second wing 54. As shown, guide member 280 may beconfigured to securely and properly hold implantable device 30, therebyensuring the appropriate engagement and alignment of first and secondsurfaces 330, 340 with pair of wings 50 to allow evenly applied bendingor crimping force, and produce symmetric displacement or bending of pairof wings 50.

FIG. 3B illustrates an end view of surgical instrument 20 of FIG. 2Aengaging interspinous implantable device 30 before compression ofimplant wings 50. As noted previously, guide member 280 may beconfigured to engage top a surface 56 of device 30. Further, firstelongated section 220 and second elongated section 230 may be positionedon opposite sides of implantable device 30 and may engage outer surfacesof wings 52, 54. As shown, first handle portion 200 and second handleportion 210 are in an open position, and a surgeon may compress firsthandle 200 and second handle 210 together to move first elongatedsection 220 and second elongated section 230 toward one another andthereby apply a compressive force to the wings 52, 54 sufficient to bendwings 52, 54 inward, as shown in FIG. 3C, to engage a spinous process(not shown) located therebetween.

It is also contemplated that the surgeon may elect to use the surgicalinstrument 20 to pre-bend the implantable device 30 prior to insertion,such as for example, where the spinous process is relatively thin andthe surgeon may decide that a pre-shaped or preloaded implantable device(i.e., one where the wings 52, 54 of a pair of wings 50 are crimpedtogether to form a narrower gap therebetween) would enable a better fit.Alternatively, the surgeon may elect to use surgical instrument 20 topre-bend implantable device 30 prior to insertion such that the distanceor gap between wings 52, 54 is slightly smaller than the width of thespinous process to be placed therebetween. This latter scenario may bedesirable for a surgeon when taking into account the degree offlexibility or elasticity of wings 50, 60, which would enable wings 50,60 to act as a clip on a spinous process.

FIG. 3D illustrates a perspective end view of the underside of thesurgical instrument of FIG. 3A, according to an exemplary embodiment. Asshown, guide member 280 can include a distal extension 290. Distalextension 290 can provide a relatively thicker material region that willprovide additional rigidity to guide member 280, thereby preventingbending of guide member 280 during use. In some embodiments, distalextension 290 can further include a hook section 292 configured tooverlap end region 294 of first elongated section 220 and secondelongated section 230, thereby further preventing bending of guidemember 280.

As noted previously, guide member 280 may be maintained at a fixedsymmetric position with respect to first elongated section 220 andsecond elongated section 230. As guide member 280 may engage implantabledevice 30 before compression, the fixed relative position of guidemember 280 may facilitate equal distribution of compressive forces onwings 52, 54. This configuration may assist a surgeon in securelyattaching implantable device 30 to a spinous process by securing wing 52and wing 54 in approximately symmetric alignment with the spinousprocess.

In some embodiments, surgical instrument 20 can include additionalmechanisms to aid a physician in properly positioning instrument 20 onimplant 30. For example, referring again to FIG. 2D, instrument 20 caninclude a blocking protrusion 320 positioned on guide member 280.Blocking protrusion 320 can be positioned on an upper surface of guidemember 280 such that it will contact a portion of implant 30 engaged byguide member 280 and prevent implant 30 from moving too far into guidemember 280. Further, it will be understood that the position and size ofblocking protrusion 320 can be selected based on the size andconfiguration of a selected implant 30 and/or instrument 20.

FIG. 4 illustrates a portion of a kit or surgical set 400, including asurgical instrument 410 and implantable device 30, according to anexemplary disclosed embodiment. As shown, implantable device 30 maycomprise an interspinous implant similar to that described above withreference to FIG. 1. As noted previously, implantable device 30 mayinclude at least one pair of wings 50, which may be configured to engagea spinous process (not shown). During an implantation procedure, asurgeon can determine that the distance between first wing 52 and secondwing 54 is insufficient to allow the implant to be properly implanted,i.e., the spinous process is too large to fit between wings 52, 54.Therefore, it may be desirable to spread wings 52, 54 apart, therebyincreasing the distance between first wing 52 and second wing 54.Surgical instrument 410 may be used to increase the distance betweenwings 50 to facilitate implantation. Further, instrument 410 may beconfigured to provide equal bending forces to both wings 52, 54 of pairof wings 50 to bend wings 52 and wing 54 substantially symmetrically.

FIG. 5A illustrates a perspective view of surgical instrument 410 ofFIG. 4, according to an exemplary disclosed embodiment, and FIG. 5Billustrates an exploded view of the surgical instrument of FIG. 5A. Asshown, instrument 410 includes a first handle portion 420 and a secondhandle portion 430. First handle portion 420 may be connected to a firstelongated section 440, and second handle portion 430 may be connected toa second elongated section 450. First handle portion 420 may beintegrally formed with first elongated section 440, and second handleportion 430 may be integrally formed with second elongated section 450.Alternatively, the pieces may be separately formed and then joined.Further, first handle portion 420 and second handle portion 430 may bejoined at a hinge region 460. Hinge region 460 may form a rotatableconnection between first handle portion 420 and second handle portion430. As shown, hinge region 460 may include a hinge connector 470, suchas, for example, a screw, a pin, a bolt, or another type of suitableconnector.

Similar to surgical instrument 20 previously described, a leaf springmechanism 170 may also be provided between the first handle portion 420and the second handle portion 430 to provide a biased resistance-forcebetween handle portions 420, 430. Leaf spring mechanism 170 may comprisetwo leaf springs 172, 174. One leaf spring 172 may terminate into a maleportion 176, while another leaf spring 174 may terminate into a femaleportion 178, as shown. Leaf springs 172, 174 may rest against oneanother in a mobile, hinged configuration. This hinged configurationenables leaf springs 172, 174 to pivot with respect to one another. Eachof leaf springs 172, 174 may be attached to handle portions 420, 430with a fastener 190. As shown in detail in FIG. 5B, leaf springs 172,174 may attach to first and second handle portions 420, 430,respectively, by securing fasteners 190 through holes 192 on leafsprings 172, 174, and into holes 194 of the first and second handleregions 420, 430. Fasteners 190 may comprise any suitable connector suchas, for example, a screw, a bolt, or a pin, as is commonly used in theart.

A surgeon may grasp first handle portion 420 and second handle portion430, and by increasing or decreasing the distance between first handleportion 420 and second handle portion 430, may increase or decrease thedistance between first elongated section 440 and second elongatedsection 450. In one embodiment, as the distance between first handleportion 420 and second handle portion 430 is increased, the distancebetween first elongated section 440 and second elongated section 450will decrease. Conversely, as the distance between first handle portion420 and second handle portion 430 is decreased, the distance betweenfirst elongated section 440 and second elongated section 450 willincrease.

FIG. 5C illustrates an exploded view of an end region of the surgicalinstrument 410 of FIG. 5A, according to an exemplary disclosedembodiment. As shown, instrument 410 may further include a guide member480 and at least two connector pieces 490, 500. First connector piece490 may form a rotatably mobile connection with first elongated section440, and second connector piece 500 may form a rotatably mobileconnection with second elongated section 450. Connector pieces 490, 500may further form a common rotatably mobile connection 510 with oneanother. Further, connection 510 may form a common connection with guidemember 480. In some embodiments, at least one connector piece mayinclude a protrusion 512 configured to engage an elongated groove 514 inguide member 480 to form a slidable connection between connector pieces490, 500 and guide member 480. Connector pieces 490, 500 may berotatably joined at protrusion 512 and may secure guide member 480 in afixed symmetric position with respect to first elongated section 440 andsecond elongated section 450 during movement of first elongated section440 and second elongated section 450 about hinge region 460.

Similar to guide member 280 and connector pieces 260, 270, guide member480 and connector pieces 490, 500 may facilitate symmetric displacementof wings 52, 54. For example, as noted previously, due to designtolerances and production variables, the thicknesses and materialproperties of wings 52, 54 may vary slightly. Therefore, if equalbending forces are applied to each wing 52, 54 the displacement ordegree of bending achieved for each wing 52, 54 may vary, therebyproducing an asymmetric implant shape and possibly producing improperengagement with a spinous process when 52, 54 and bend towards oneanother after implantation. The guide member 480 and connector pieces490, 500 provide symmetric displacement of wings 52, 54 even when thedimensions and/or material properties of wings 52, 54 are different.

FIG. 5D illustrates a perspective view of a surgical instrument 410′,according to another exemplary disclosed embodiment. Surgical instrument410′ is identical to surgical instrument 410, but with an additionalvisual gauge element 180 similar to the one described with surgicalinstrument 20′. The gauge element 180 comprises two arms 182, 184, eacharm being attached to a handle region 420, 430, respectively, of thesurgical instrument 410′. The free ends of the arms are configured toslide against one another when the surgical instrument 410′ is engaged.Visual indicators or marks (not shown) on arms 182, 184 are aligned asthe surgical instrument 410′ is compressed or squeezed together, therebyindicating to the user the distance between implant wings 52, 64 as theyare spread apart.

FIG. 6A illustrates a perspective view of surgical instrument 410 ofFIG. 4 engaging an interspinous implant. As shown, guide member 480 isplaced around pair of wings 50 of implantable device 30. FIG. 6Billustrates an enlarged top view of surgical instrument 410 of FIG. 6Aengaging interspinous implantable device 30 before expansion of implantwings 50. As shown, guide member 480 includes two distal protrusions520, 530 positioned adjacent to outer surfaces of wings 50. Distalprotrusions 520, 530 may serve as guide ramps or bumpers, providing asupport surface against which pair of wings 50 may be bent outward.Further, first elongated section 440 may include a surface 540, andsecond elongated section 450 may include a second surface 550. As asurgeon compresses handle portions 420, 430 together, first surface 540and second surface 550 may move outwardly and exert an expanding forceon wings 50, thereby spreading wings 50 apart, as shown in FIG. 6C.Thus, surgical instrument 410 may be used as spreading pliers to evenlyexpand the distance between pair of wings 50, 60 of implantable device30 in order to accommodate an oversized interspinous processtherebetween. In some embodiments, distal protrusions 520, 530 will bepositioned equidistant from a long axis of instrument 410, therebyallowing wings 52, 54 to be evenly bent outward by applying forceagainst wings 52, 54 and protrusions 520, 530.

It is contemplated that a surgical set or kit set 10 of the presentinvention may include one or more of surgical instruments 20, 410 andmay include one or more of implantable devices 30. The surgical set orkit may further include a sizing implant for sizing an interspinousspace that will receive an implant. Alternatively, it is possible toprovide an instrument set without an implantable device and/or sizingimplement. The surgical instruments 20, 410 may be configuredspecifically to be used with the implantable device 30 provided with thesurgical set or kit. The surgical instruments 20, 410 can be calibratedto either bend together or spread apart a pair of wings 50, 60 within apredetermined range of angles and forces, so as not to overextend thewings 50, 60 and cause damage, weakening, or breakage.

To implant device 30, a surgeon will first expose the interspinous spaceto be treated using an incision near the selected vertebral levels.Next, the surgeon will partially or completely remove the posteriorspinal ligaments at the selected vertebral level. Then, to make spacefor an implantable device 30, the surgeon will remove part or all of theinterspinous ligament.

Prior to implantation of implantable device 30, the surgeon may sizeand/or shape the selected interspinous space. FIG. 7A illustrates aportion of a surgical kit, including a sizing and insertion implement700, according to an exemplary disclosed embodiment. As shown, implement700 includes a first sizing end 710 that can be inserted between twospinous processes 702, 704. Sizing end 710 is configured to have a sizeand shape approximately matching the size and shape of an implantabledevice of a surgical kit, thereby allowing a surgeon to test the size ofan implantable device before implantation. Further, as noted previously,the surgical kits of the present disclosure can include implants havinga variety of different sizes, and accordingly, the kit can furtherinclude sizing implements corresponding to the size of each implant.

The surgical kits of the present disclosure can further includeinsertion implements. For example, in some embodiments, implement 700can include a second implantation end 720. For example, FIG. 7Billustrates the implement of FIG. 7A engaging an interspinous implant30, according to an exemplary disclosed embodiment. As shown,implantation end 720 is configured to engage a space between U-shapedbody 40 of implant 30, thereby allowing a surgeon to manipulate device30 and push device 30 into a selected anatomic space. Alternatively,surgical instrument 20, as described above, can be used to grasp animplant 30 to facilitate manipulation and insertion.

It should be noted that a number of variations to the implantationtechnique and selected implantable device are envisioned. For example,in some embodiments, the spinous processes may be cut or shaped prior toimplantation of selected devices. Suitable devices for shaping spinousprocesses are described in detail in co-pending U.S. patent applicationSer. No. 11/676,141 to Rudolf Bertagnoli et al., which is titled,“Method and System for Performing Interspinous Space Preparation forReceiving an Implant,” and which is hereby incorporated by reference inits entirety.

In addition, suitable implantable devices 30 can include surfaceprojections 725, barbs, or other features on the device body or innersurfaces of the wing members. These surface projections 725 can furtherimprove attachment of the device to spinous processes. In addition, insome embodiments, a surgeon may secure an implant to a spinous processby forming a hole transversely through the spinous process and placing ascrew, rivet or other connection through the hole in the spinous processand through a hole 722 in at least one of the elongated wing members ofan implantable device 30. Such a process is disclosed in U.S.Provisional Patent Application No. 60/868,080, filed Nov. 30, 2006 andentitled “Interspinous Vertebral Stabilization System,” which is herebyincorporated by reference in its entirety. Further, as noted previously,other suitable implantable devices can be selected, including devicesused to treat various vertebral levels including vertebral levelsadjacent the lumbosacral region 730.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1-42. (canceled)
 43. A method of securing an implant adjacent a spinousprocess, comprising: selecting an implant having a body portion and atleast two elongated wing members configured to engage opposite sides ofa vertebral spinous process; positioning the body portion adjacent afirst spinous process; and substantially evenly displacing each wingmember in a first direction relative to a center point between the twoelongated wing members to move the two elongated wing members toward oneanother to secure the elongated wing members on opposite sides of aspinous process.
 44. The method of claim 43, wherein the step ofsubstantially evenly displacing includes using a surgical instrument tosubstantially simultaneously engage the two wing members and move thetwo wing members toward one another.
 45. The method of claim 44, whereinthe step of substantially evenly displacing further includes engaging afirst wing of the two wing members with a surface of a first elongatedsection of the surgical instrument and engaging a second wing of the twowing members with a surface of a second elongated section of thesurgical instrument.
 46. The method of claim 45, wherein the step ofsubstantially evenly displacing further includes applying a first forceto the first wing via the first elongated section and applying a secondforce to the second wing via the second elongated section, wherein thefirst and second forces are not equal.
 47. The method of claim 47,wherein the surgical instrument comprises a crimping plier.
 48. Themethod of claim 45, wherein the elongated wing members are permanentlyattached to the implant body.
 49. The method of claim 45, whereinpositioning the implant body includes positioning the implant bodybeneath the first spinous process such that the wing members attached tothe implant body are positioned on opposite sides of the first spinousprocess.
 50. The method of claim 45, further including substantiallyevenly displacing the two elongated wing members in a second directionrelative to the center point between the two elongated wing members, thesecond direction being opposite to the first direction, to spread apartthe two elongated wing members before positioning the implant bodyportion adjacent the first spinous process.
 51. The method of claim 50,wherein the step of substantially evenly displacing the two elongatedwing members in a second direction includes using a surgical instrumentto substantially simultaneously engage the two wing members and move thetwo wing members away from one another.
 52. The method of claim 51,wherein the step of substantially evenly displacing the two elongatedwing members in the second direction further includes engaging a firstwing of the two wing members with a surface of a first elongated sectionof the surgical instrument and engaging a second wing of the two wingmembers with a surface of a second elongated section of the surgicalinstrument.
 53. The method of claim 52, wherein the step ofsubstantially evenly displacing the two elongated wing members in thesecond direction further includes applying a first force to the firstwing via the first elongated section and applying a second force to thesecond wing via the second elongated section, wherein the first andsecond forces are not equal.
 54. The method of claim 53, wherein thesurgical instrument comprises spreading pliers.
 55. The method of claim45, wherein the implant includes two elongated wing members extending ina superior direction with respect to the implant body and two elongatedwing members extending in an inferior direction with respect to theimplant body.
 56. The method of claim 45, wherein at least one of the atleast two elongated wing members includes surface projections on atleast one inner surface of a wing member to secure the implant to thebone of a spinous process.
 57. The method of claim 45, wherein theimplant body includes surface projections to secure the implant to thebone of a spinous process.
 58. The method of claim 45, further includingcreating a transversely-oriented opening through the first spinousprocess.
 59. The method of claim 56, further including securing the twoelongated wing members to the transversely-oriented opening in the firstspinous process. 60-72. (canceled)